Acute stage of thrombotic superficial phlebitis of the limbs
Conditions
Interventions
The test drug group:jingmaiyan granules
placebo group:jingmaiyan granules Simulator
Sponsors
Shanghai University of Traditional Chinese Medicine Affiliated Shuguang Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Meets the Western medical diagnostic criteria for the acute stage of thromboangiitis obliterans of the extremities; (2) Meets the diagnostic criteria of the syndrome of blood heat and stasis accumulation in traditional Chinese medicine; (3) The disease course at the time of consultation is = 5 days; (4) The pain NRS score at the time of consultation is = 4 points; (5) Age between 18 and 70 years old (inclusive at both ends), gender not restricted; (6) Has given informed consent and signed the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients with thrombophlebitis of the chest and abdominal wall or migratory thrombophlebitis; (2) Patients with gangrene-like conditions, skin nodular polyarteritis, thromboangiitis obliterans, Behcet's disease, Bazin's erythema, etc.; (3) Patients with active ulcers that have not healed or other severe conditions requiring surgical treatment in the target vessels; (4) Patients with active tumors, intermuscular venous thrombosis, etc. of deep vein thrombosis; (5) Patients with skin and soft tissue infectious diseases, such as acute erysipelas, carbuncle, acute lymphangitis, acute cellulitis, etc.; (6) Patients with severe primary diseases in important organs and systems, such as heart, liver, kidney, hematopoietic system, etc.; (7) Patients suspected or confirmed to have alcohol addiction, drug abuse history, or those with cognitive impairment, severe mental illness and unable to cooperate with the completion of clinical trials; (8) Patients who have received therapeutic methods such as drugs, traditional Chinese medicine external treatment, non-drug therapy, physical therapy, etc. that may affect the evaluation of therapeutic effect after the onset of the disease; (9) Patients with white blood cell or neutrophil count exceeding the upper limit of the reference value of this center; (10) Patients with blood Cr exceeding the upper limit of the reference value; ALT or AST exceeding 1.5 times the upper limit of the reference value for any one of them; (11) Pregnant women or women preparing for pregnancy within 6 months; (12) Patients with allergic constitution, such as those allergic to two or more drugs or foods, or those who are known to be allergic to the ingredients of the drugs used in this study; (13) Patients who have participated in other clinical trials within 30 days before screening; (14) Patients judged by the investigator to be unsuitable for participating in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of disappearance of clinical symptoms after 14 days of medication application; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time of disappearance of clinical symptoms;The rate of disappearance of clinical symptoms after 7 days of medication and another 7 days after discontinuation of the medication;The changes in the NRS pain scores compared to the baseline after 7 days, 14 days of medication use, and 7 days after discontinuation of the medication.;The changes in TCM syndrome scores compared to the baseline after 7 days and 14 days of medication application;Efficacy of the treatment after 14 days of medication;The time of disappearance and the disappearance rate of individual symptoms;The changes in blood inflammatory indicators compared to the baseline level; | — |
Countries
China
Contacts
Public ContactLiu Guobin
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Outcome results
None listed